NURITE II— 510(k) K780828

Substantially Equivalent

Bio-Medical Systems Corp.

FDA 510(k) clearance K780828 for NURITE II, Substantially Equivalent on 1978-05-31. Applicant: Bio-Medical Systems Corp.. Device class: 2.

Clearance details

Applicant: Bio-Medical Systems Corp.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1978-05-19
Decision date: 1978-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZJ

K252712 — STIMPOD NMS460 Nerve Stimulator2026-05-28
K252767 — actiTENS mini2026-01-16
K252236 — CP Relief Wand Rx - TENS/NMES2025-08-15
K232441 — Unipro (K-UNIPRO-US)2024-08-30
K241228 — TENSWave2024-08-27

More clearances from Bio-Medical Systems Corp.

K791833 — NURITE II VRM SINGLE (ELEC. NERVE STIM)1979-10-02
K791834 — NURITE II VRM DUAL (ELEC. NERVE STIM.)1979-10-02
K781683 — NURITE II, SINGLE1978-10-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.